Vanda Pharmaceuticals has been granted a patent for a process to produce highly purified tasimelteon, a pharmaceutical compound. The process involves analyzing the synthesized tasimelteon for impurities and ensuring the final composition contains 0.15 wt % or less of Impurity 5. GlobalData’s report on Vanda Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.
Smarter leaders trust GlobalData
According to GlobalData’s company profile on Vanda Pharmaceuticals, Peptide pharmacophores was a key innovation area identified from patents. Vanda Pharmaceuticals's grant share as of September 2023 was 38%. Grant share is based on the ratio of number of grants to total number of patents.
A recently granted patent (Publication Number: US11760740B2) discloses a composition comprising tasimelteon, a pharmaceutical compound used for the treatment of sleep disorders. The composition is prepared through a specific process involving several steps.
The first step involves the reaction of (1R,2R)-2-(2,3-dihydrobenzofuran-4-yl) cyclopropane carboxamide with a reducing agent, such as LiAlH4. This reaction is followed by the contact of the resulting product with an acid, such as HCl, in an organic solvent (TBME), resulting in the formation of ((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl) methanamine or a salt thereof.
The next step in the process is the reaction of ((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methanamine with a propionylating reagent, such as propionyl chloride. This step may also involve the use of an organic solvent and a base, such as NaOH.
The composition of tasimelteon obtained through this process has specific requirements. It should contain 0.15 wt % or less of Impurity 5, which is N-((2-(2,3-dihydrobenzofuran-4-yl)-1-((2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl) (propionamido)methyl) cyclopropyl)methyl)propionamide. Additionally, the composition should have 0.15 wt % or less of each of Impurity 1, Impurity 2, and Impurity 3, as well as 0.15 wt % or less of each of Impurity 4 and Impurity 7. Furthermore, the composition should contain 100 ppm or less of ethyl diazaoacetate (EDA).
The patent also mentions the possibility of crystallizing the tasimelteon and assaying it for the presence of Impurity 5 and Impurity 6, which is 2-hydroxy-6-(2-(propionamidomethyl)cyclopropyl)phenethyl 2-(2-hydroxyethyl)-3-(2-(propionamidomethyl)cyclopropyl)phenyl carbonate. The reducing agent LiAlH4 and the acid HCl may be used in this crystallization process.
The patent further includes the use of the composition in pharmaceutical formulations, where it is combined with pharmaceutically acceptable excipients.
In summary, the granted patent describes a specific process for preparing a composition of tasimelteon, a pharmaceutical compound used for sleep disorders. The composition has specific requirements regarding impurities and can be used in pharmaceutical formulations.
To know more about GlobalData’s detailed insights on Vanda Pharmaceuticals, buy the report here.
Data Insights
From
The gold standard of business intelligence.
Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.
GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
